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Trial record 1 of 1 for:    NCT00692770
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Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bayer Identifier:
First received: June 5, 2008
Last updated: September 11, 2014
Last verified: September 2014

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 140 months from first patient first visit ] [ Designated as safety issue: No ]
  • Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire. [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]
  • Evaluation of biomarkers. [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]

Enrollment: 1114
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
Placebo Comparator: Arm 2 Drug: Placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
  • At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
  • Male or female subjects >/= 18 years of age
  • Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
  • For subjects undergoing surgical resection pathology proven complete removal of tumor.
  • Intermediate or High Risk of recurrence as assessed by tumor characteristics.
  • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
  • ECOG Performance Status of 0.
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Recurrent HCC
  • Child-Pugh score 7 points with presence of ascites.
  • Low risk of recurrence after curative treatment
  • History of cardiovascular disease
  • History of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
  • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Subjects with evidence or history of bleeding diathesis
  • Subjects undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy
  • History of GI bleeding within 30 days of randomization.
  • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
  • Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
  • Liver transplantation, this includes patients on a transplant list with the intention to transplant
  Contacts and Locations
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Please refer to this study by its identifier: NCT00692770

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United States, Alabama
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Phoenix, Arizona, United States, 85054
United States, California
La Jolla, California, United States, 92093-0987
Los Angeles, California, United States, 90095-7077
Los Angeles, California, United States, 90033
San Francisco, California, United States, 94115
United States, District of Columbia
Washington, District of Columbia, United States, 20007
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Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30309-1231
Atlanta, Georgia, United States, 30322
United States, Indiana
Indianapolis, Indiana, United States, 46202
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Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
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Baltimore, Maryland, United States, 21287
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Ann Arbor, Michigan, United States, 48109
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Minneapolis, Minnesota, United States, 55407
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New York, New York, United States, 10029
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Cleveland, Ohio, United States, 44106
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Portland, Oregon, United States, 97213
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Pittsburgh, Pennsylvania, United States, 15213
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Houston, Texas, United States, 77030
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Richmond, Virginia, United States, 23249
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Madison, Wisconsin, United States, 53791-6164
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Calgary, Alberta, Canada, T2N 4N1
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Vancouver, British Columbia, Canada, V5Z 4E6
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Montreal, Quebec, Canada, H3A 1A1
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Guangzhou, Guangdong, China, 510060
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Nanning, Guangxi, China, 530021
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Wuhan, Hubei, China, 430022
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Changsha, Hunan, China, 410008
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Nanjing, Jiangsu, China, 210002
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Xi'an, Shanxi, China, 710038
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Chengdu, Sichuan, China, 610072
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Hangzhou, Zhejiang, China, 310022
Beijing, China, 100853
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Chongqing, China, 400038
Dalian, China, 116027
Hefei, China, 230022
Shanghai, China, 200438
Shanghai, China, 200032
Shanghai, China, 200001
Tianjin, China, 300060
ANGERS cedex 09, France, 49933
Bondy, France, 93143
Bordeaux, France, 33000
Creteil, France, 94010
Lille, France, 59037
LYON Cedex 04, France, 69317
Marseille, France, 13005
Nice, France, 06202
Paris, France, 75020
Paris, France, 75571
Rennes Cedex, France, 35062
Toulouse, France, 31059
Vandoeuvre-les-nancy, France, 54500
Villejuif, France, 94800
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München, Bayern, Germany, 81377
München, Bayern, Germany, 81675
Regensburg, Bayern, Germany, 93042
Göttingen, Niedersachsen, Germany, 37075
Hannover, Niedersachsen, Germany, 30625
Aachen, Nordrhein-Westfalen, Germany, 52074
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Essen, Nordrhein-Westfalen, Germany, 45147
Köln, Nordrhein-Westfalen, Germany, 50937
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg/Saar, Saarland, Germany, 66421
Halle/Saale, Sachsen-Anhalt, Germany, 06120
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Berlin, Germany, 12200
Hamburg, Germany, 20246
Athens / Greece, Greece, 115 27
Larissa, Greece, 41111
Thessaloniki, Greece, 540 07
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San Giovanni Rotondo, Foggia, Italy, 71013
Bari, Italy, 70124
Benevento, Italy, 82100
Bologna, Italy, 40138
Cagliari, Italy, 09134
Catania, Italy, 95122
Milano, Italy, 20133
Milano, Italy, 20121
Modena, Italy, 41124
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Padova, Italy, 35128
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Roma, Italy, 00168
Torino, Italy, 10126
Kashiwa, Chiba, Japan, 277-8577
Kanazawa, Ishikawa, Japan, 920-8641
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Osakasayama, Osaka, Japan, 589-8511
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Kyoto, Japan, 606-8507
Okayama, Japan, 700-8558
Osaka, Japan, 537-8511
Tokushima, Japan, 770-8503
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Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 700721
Goyang-si, Gyeonggido, Korea, Republic of, 411-706
Goyang-si, Gyeonggido, Korea, Republic of, 410-769
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 135-720
Busan, Korea, Republic of, 602-739
Jeollabuk-do, Korea, Republic of, 561-712
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Monterrey, Nuevo Leon, Mexico, 64710
México, D.F., Mexico, 14080
México, D.F., Mexico, 14050
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Auckland, New Zealand, 1023
Christchurch, New Zealand, 8011
Chiclayo, Peru, CIX
Lima, Peru, LIMA 11
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Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1069-166
Bucharest, Romania, 022326
Bucharest, Romania, 11172
Cluj-Napoca, Romania, 400015
Iasi, Romania, 700106
Iasi, Romania, 700111
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Moscow, Russian Federation, 115478
Moscow, Russian Federation, 119992
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St. Petersburg, Russian Federation, 197758
Voronezh, Russian Federation, 394000
Singapore, Singapore, 169608
Singapore, Singapore, 119228
Oviedo, Asturias, Spain, 33006
Sabadell, Barcelona, Spain, 08208
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Córdoba, Spain, 14004
Madrid, Spain, 28040
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Valladolid, Spain, 47012
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Stockholm, Sweden, 141 86
Bern, Switzerland, 3010
Zürich, Switzerland, 8091
Changhua, Taiwan, 500-06
Kaohsiung City, Taiwan, 807
Kaohsung, Taiwan, 833
Tainan, Taiwan, 704
Taipei, Taiwan, 112
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
United Kingdom
Southampton, Hampshire, United Kingdom, SO16 6YD
Greater Manchester, Manchester, United Kingdom, M20 4BX
Birmingham, West Midlands, United Kingdom, B15 2TT
Leeds, West Yorkshire, United Kingdom, LS9 7TF
London, United Kingdom, SE5 9RS
London, United Kingdom, NW3 2QG
London, United Kingdom, EC1M 6BQ
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT00692770     History of Changes
Other Study ID Numbers: 12414, 2008-001087-36
Study First Received: June 5, 2008
Last Updated: September 11, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Austria: Ethikkommission
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Greece: Ethics Committee
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Russia: Ethics Committee
Switzerland: Swissmedic
Sweden: Ethikkommission
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Food and Drug Administration
Japan: National Institute of Health Sciences
Hong Kong: Department of Health
Korea: Food and Drug Administration
New Zealand: Medsafe
Singapore: Health Sciences Authority
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
Hepatocellular carcinoma
Surgical resection
Adjuvant therapy
Liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 20, 2014